ORBIT GALAXY 640CF0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886704030263), received between Dec 30, 2016 and Jan 9, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WHO WAS SUFFERING FROM AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION. AFTER THE ACCESS WAS ESTABLISHED, THE STENT MICROCATHETER REACHED THE A2 SEGMENT AND EMBOLIZATION WAS INITIATED AFTER THE MICROCATHETER FOR THE COIL (UNSPECIFIED BRAND) WAS IN PLACE. THE FIRST FOUR (4) COILS WERE AVENIR® COIL SYSTEM (WALLABY MEDICAL) FOLLOWED BY TWO (2) GALAXY 8MM X 7CM (PENDING DEVICE CLARIFICATION). THEN A 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0615 / 30558301) WAS USED. IT WAS FOUND THAT THE MICROCATHETER KICKED BACK WHILE THE COIL WAS BEING POSITIONED IN THE TARGET ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WAS DISSATISFIED WITH THE AREA OF ANEURYSM EMBOLIZATION AND TRIED TO RETRACT THE STENT. WHEN HALF OF THE 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL WAS WITHDRAWN, IT WAS FOUND THAT THE COIL HAD BECOME PREMATURELY DETACHED IN THE PATIENT¿S BODY WITHOUT THE DETACHMENT INITIATION. THE MICROCATHETER THAT WAS USED FOR THE COIL WAS RETRACTED AND THE 6MM X 15CM ORBIT GALAXY COMPLEX FILL COIL WAS REMOVED BY RELEASING THE SOLITAIRE¿ STENT RETRIEVER (MEDTRONIC). THE 6MM X 15CM ORBIT GALAXY

  Patient problems: Thrombosis/Thrombus; Vasoconstriction

  MAUDE report 16127384 ↗
• MalfunctionNov 17, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN TRIED TO RETRACT THE 4MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0410 / 30683879) BECAUSE ITS SHAPE WAS NOT IDEAL, BUT THE COIL WAS OBSERVED TO HAVE BECOME UNRAVELED / STRETCHED. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 10-NOV-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INTENDED PROCEDURE TARGET VESSEL IS NOT KNOWN; THE ANEURYSM SIZE AND CHARACTERISTICS ARE UNKNOWN. THE MICROCATHETER USED WAS A CERENOVUS MICROCATHETER, HOWEVER, THE CATALOG AND LOT NUMBER IS NOT KNOWN. THE INFORMATION INDICATED THAT THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED, HOWEVER, THE NUMBER OF TIMES IT HAD BEEN WITHDRAWN AND REPOSITIONED WAS NOT REPORTED. PRIOR TO THE COMPLAINT COIL, TWO OTHER COILS WENT THROUGH THE MICROCATHETER WITHOUT ANY RESISTANCE. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED UNRAVELED / STRETCHED CONDITION WHEN IT WAS REMOVED. THE REPORTED EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 4MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816111 ↗
• MalfunctionOct 20, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4X10 ORBIT GALAXY COIL (640CF0410, 30679270) WAS USED AS THE FIRST COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. BECAUSE THE COIL'S SIZE WAS NOT APPROPRIATE FOR THE ANEURYSM. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED INSIDE OF THE INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639020 ↗
• InjuryJun 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 55-YEAR-OLD PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF CONTROLLED HYPERLIPIDAEMIA, HYPERTENSION, CURRENT SMOKER SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM WITH HUNT & HESS GRADE 1, MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 6.4MM, DOME 6.5MM, MAXIMUM ANEURYSM DIAMETER 8.6MM, NECK SIZE 3.3MM, AND DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.4MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX (6) CERENOVUS COILS: A 4MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0410 / 30396173), A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 30393990), A 7MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0715 / 304722037), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30396174), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30451949), AND A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0202 / 30432544) VIA A PROWLER SELECT PLUS MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMP

  Patient problems: Aneurysm

  MAUDE report 14603855 ↗
• MalfunctionJun 1, 2022Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 4MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0410 / 30606912) MADE A HELICAL SHAPE EVEN THOUGH THIS COIL IS NOT SUPPOSED TO FORM THIS SHAPE. AFTER THIS ISSUE WAS DETECTED DURING THE PROCEDURE MONITORING STEP, THE PHYSICIAN RETRACTED THE COIL AND FULLY REMOVED IT FROM THE PATIENT. THERE WAS A DELAY REPORTED, THE DURATION OF THE DELAY WAS NOT REPORTED. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566588 ↗
• MalfunctionMar 30, 2022Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 4MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0410 / 30579156) MADE A HELICAL SHAPE EVEN THOUGH THIS COIL IS NOT SUPPOSED TO FORM THIS SHAPE. AFTER THIS ISSUE WAS DETECTED DURING THE PROCEDURE MONITORING STEP, THE PHYSICIAN RETRACTED THE COIL AND FULLY REMOVED IT FROM THE PATIENT. THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13954088 ↗
• MalfunctionJan 12, 2021Retraction Problem; Difficult to Advance; Retraction Problem; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4X10 OG TDL CMPLX FILL COIL (640CF0410, 30379639) WAS BEING USED AS THE FIRST COIL. THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING THE ORBIT GALAXY COIL THROUGH HEADWAY MICROCATHETER (MC). THE COIL WAS JAMMED INSIDE OF THE CATHETER AND NOT AVAILABLE TO BE TAKEN OUT OF THE CATHETER. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154305 ↗
• MalfunctionApr 7, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE TWO ORBIT GALAXY COMPLEX FILL 4X10 COILS STRETCHED. THE PHYSICIAN REMOVED THE TWO STRETCHED COILS SAFELY. ANOTHER ORBIT GALAXY XTRASOFT 2.5 X 3.5 COIL FAILED TO RESHEATH WHEN THE PHYSICIAN TRIED TO REMOVE THE COIL, ANOTHER COIL OF A DIFFERENT SIZE WAS USED. THE PROCEDURE WAS COMPLETED. THERE WERE NO SERIOUS INJURIES DUE TO THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6472552 ↗
• MalfunctionApr 7, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, TWO ORBIT GALAXY COMPLEX FILL 4X10 COILS STRETCHED. THE PHYSICIAN REMOVED THE TWO STRETCHED COILS SAFELY. ANOTHER ORBIT GALAXY XTRASOFT 2.5 X 3.5 COIL FAILED TO RESHEATH WHEN THE PHYSICIAN TRIED TO REMOVE THE COIL, ANOTHER COIL OF A DIFFERENT SIZE WAS USED. THE PROCEDURE WAS COMPLETED. THERE WERE NO SERIOUS INJURIES DUE TO THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6472542 ↗
• MalfunctionDec 30, 2016Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PROCEDURE, THE ORBIT GALAXY COIL (640CF0410/ 175410090) STRETCHED. THE PHYSICIAN REMOVED THE COIL SAFELY AND USED ANOTHER SAME SIZE COIL, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO POTENTIAL ADVERSE EVENTS. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6215864 ↗